Neonatal

Trials to achieve healthy outcomes for mothers and babies are
challenging. We work with clinicians through global partnerships,
aiming to find cost-effective treatments that will reduce
infant mortality and illness.

The data from our latest trials are being combined with data
from similar trials in other countries for prospective
meta-analysis of data from many thousands of
patients. We have participated or taken a lead in setting
up networks of investigators who are making this happen.

Planned trials - Coming
soon!

Active trials - Recruiting

The Lactoferrin Evaluation in Anaemia in Pregnancy
(LEAP-1) study will evaluate the effects of oral bovine
lactoferrin versus iron sulphase in iron deficiency anaemia in
pregnancy. The study aims to see if bovine lactoferrin
administration during pregnancy improves foetal growth and neonatal
iron status at birth.

The PAEAN study will examine the effect of
erythropoietin in near-term babies who have suffered from low blood
or oxygen supply to the brain at birth. PAEAN aims to find out
whether erythropoietin in addition to the standard of care
treatment increases survival without moderate to severe disability
at 2 years of age.

The PROTECT study will evaluate the effect of
pentoxifylline for preterm babies with late-onset sepsis or
necrotizing enterocolitis. The study aims to see if pentoxifylline
improves survival without disability in these babies.

The TORPIDO2 study is trying to find out how much
oxygen is best for very premature babies. It will compare short and
long term outcomes of premature babies who have had one of two
different but commonly used levels of oxygen, to see if using
higher or lower levels in the perios just after birth is better the
for baby in the short and long term.

Active trials - Follow-up

The Australian Placental Transfusion
Study (APTS) will determine whether a 60-second delay
in clamping and cutting the cord can improve the baby's blood flow
to the brain and gut, reduce the need for donor blood, and reduce
rates of infection, retinopathy, poor growth, death and
disability in babies born more than 10 weeks early.

The Lactoferrin Infant Feeding Trial (LIFT) will evaluate the
effects of treatment with bovine lactoferrin in breast milk or
formula feeds for infants weighing less than 1500g at birth. The
aim of the study is to see if adding bovine lactoferrin to feeds
increases survival without major morbidity in very low birth weight
infants.

Closed trials

BOOSTII (Benefits of Oxygen Saturation
Targeting, trial II) will ascertain which of two oxygen saturation
ranges is better for very premature babies. Oxygen is the most
common therapy for preterm infants. Doctors and nurses do not know
the safe and effective level of oxygenation for these babies.
Higher oxygen levels may increase retinopathy of prematurity and
respiratory problems, but lower oxygen levels may affect other
long-term outcomes. BOOST II has recruited 1135 infants
in Australia (a total of 1475 with the recruitment by our
colleagues in New Zealand). Go to the BOOSTII homepage here.

The INIS trial (International Neonatal
Immunotherapy Study) assessed the effects of nonspecific
intravenous immunoglobulin in addition to antibiotics in babies
with severe infections. This trial is now closed after enrolling
just under 3500 infants. Our global partners are in New
Zealand, the United Kingdom and Argentina.